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| Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004127 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia |
| Study Start Date: | February 2000 |
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin, fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall survival of this patient population receiving this regimen. III. Determine the toxicity, including neurotoxicity, of this regimen in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive at least 3 additional courses of therapy.
Patients are followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the esophagus or gastric cardia Stage IV or recurrent Bidimensionally measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin normal SGOT less than 2 times upper limit of normal (ULN) Renal: BUN less than 1.5 times ULN Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure No unstable angina pectoris No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics appropriate for study No uncontrolled concurrent illness No active infection No clinical evidence of peripheral neuropathy by physical exam or history
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors during the first course of study Chemotherapy: More than 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for carcinoma of the esophagus or gastric cardia No prior fluorouracil Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy in HIV-positive patients No other concurrent anticancer agents
Contacts and Locations| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Illinois | |
| Cancer Care Specialists of Central Illinois, S.C. | |
| Decatur, Illinois, United States, 62526 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| Columbia LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Inc. | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Michiana Hematology/Oncology P.C. | |
| South Bend, Indiana, United States, 46617 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Michigan | |
| Lakeland Medical Center - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Grant/Riverside Methodist Hospitals | |
| Columbus, Ohio, United States, 43214 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Ann M. Mauer, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000067355, UCCRC-10015, NCI-T99-0010 |
| Study First Received: | December 10, 1999 |
| Last Updated: | January 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004127 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV gastric cancer recurrent gastric cancer stage IV esophageal cancer |
recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
|
Antimetabolites Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Leucovorin Oxaliplatin Stomach Diseases Stomach Neoplasms Vitamins Neoplasm Metastasis Micronutrients Digestive System Neoplasms Vitamin B Complex Trace Elements |
Esophageal Cancer Immunosuppressive Agents Recurrence Carcinoma Calcium, Dietary Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Fluorouracil Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Leucovorin Oxaliplatin Stomach Diseases Neoplasms by Site Stomach Neoplasms Therapeutic Uses |
Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |
